iTAPP: Topical Aprepitant in Prurigo Patients

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01963793
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Drug: Aprepitant; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Topical Aprepitant in Prurigo Patients An Exploratory Phase IIa Trial With Topically Applied Aprepitant in Patients With Prurigo
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: placebo (left) / aprepitant (right) placebo (on defined treatment area on left side of the body) / aprepitant (on defined treatment area on right side of the body)	Drug: Aprepitant; Aprepitant gel (10 mg/g); Other Names: Aprepitant gel ; Drug: Placebo; gel without active component; Other Names: aprepitant gel vehicle
Other: aprepitant (left) / placebo (right) aprepitant (on a treatment area on the left side of the body) / placebo (on a treatment area on the right side of the body)	Drug: Aprepitant; Aprepitant gel (10 mg/g); Other Names: Aprepitant gel ; Drug: Placebo; gel without active component; Other Names: aprepitant gel vehicle

Outcome Measures

Primary Outcome Measures

1. Pruritus by VAS (Visual Analogue Scale) [At end of treatment (Day 28)]

   At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

Secondary Outcome Measures

1. Pruritus by VAS (Visual Analogue Scale) [At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42]

   At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

2. Change From Baseline in Participants' Global Assessment on Treatment Areas [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.

3. Clinical Score Assessment of Crusting [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Crusts Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.

4. Clinical Score Assessment of Erythema [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Erythema Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.

5. Clinical Score Assessment of Scratch Artefacts [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Scratch artefacts: Superficial damage to the skin caused by severe scratching. Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.

6. Clinical Score Assessment of Infiltration [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Infiltration Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.

7. Transepidermal Water Loss (TEWL) [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The (sub)investigator will made the following clinical assessment: Transepidermal water loss was defined as amount of released water from skin surface in g/cm^2 per hour. The TEWL is increased in case of damage of skin barrier.

8. Lesional Erythema by Mexameter [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

9. Non-lesional Erythema by Mexameter [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

   The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

10. Melanin by Mexameter [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

11. Non-lesional Melanin by Mexameter [At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42]

    The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.

12. Daily Assessments of Duration of Pruritus (Preceding 12 Hours) [From baseline to Day 31]

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours). Duration of pruritus was categorized as follows: 1 if <0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.

13. Daily Assessments of Average Pruritus by Use of a VAS [From baseline to Day 31]

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.

14. Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS [From baseline to Day 31]

    During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.

15. Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment [Day 28]

    On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with Prurigo suffering from chronic pruritus

• Disease duration > six month

• Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation

• Adult male or female patients, aged 18 to 80 years

Exclusion Criteria:

• Concomitant medications that are primarily metabolized through Cytochrome P450 3A4

• Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial

• UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)

• Prescribed systemic medications are limited

• Clinically significant abnormalities in Blood analyses

• Anamnestic excessive use of alcohol or tobacco or drugs

• Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)

• Known or suspected hypersensitivity to component(s) of investigational products

• Within the last 30 days or current participation in any other interventional clinical trial

• Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month

• Previously enrolled/randomised in this clinical trial

• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)

• Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding

• Females of child-bearing potential with positive pregnancy test

• Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergie-Zentrum-Charité, Charité - Universitätsmedizin Berlin	Berlin		Germany	D-10117

Sponsors and Collaborators

• LEO Pharma

Investigators

• Principal Investigator: Maurer (ICI) Marcus, Prof. Dr. med., Allergie-Centrum-Charité, Charité Universitätsmedizin Berlin, Charitéplatz1, D-10117 Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01963793
• Other Study ID Numbers: LP0066-1019
• First Posted: Oct 16, 2013
• Last Update Posted: Jul 16, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by LEO Pharma: Pruritus
• Additional relevant MeSH terms: Pruritus; Prurigo; Aprepitant; Fosaprepitant

Study Results

Participant Flow

Arm/Group Title	Aprepitant Gel / Aprepitant Gel Vehicle
Arm/Group Description	Participants were treated with aprepitant on one extremity and vehicle gel on the other 1:1 thus acting as their own intra-individual controls 10 participants: LEFT: aprepitant 10 mg/g gel , RIGHT: vehicle gel and 10 participants: LEFT: vehicle gel RIGHT: aprepitant 10 mg/g gel
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Aprepitant Gel / Aprepitant Gel Vehicle
Arm/Group Description	All 20 randomised participants were divided into two groups 1:1 10 with LEFT: aprepitant 10 mg/g gel and RIGHT: vehicle gel and 10 with LEFT: vehicle gel and RIGHT: aprepitant 10 mg/g gel
Overall Participants	20
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	62.8 (11.3)
Sex: Female, Male (Count of Participants)
Female	13 65%
Male	7 35%
Region of Enrollment (Count of Participants)
Germany	20 100%

Outcome Measures

1. Primary Outcome

Title	Pruritus by VAS (Visual Analogue Scale)
Description	At end of treatment (Day 28) participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.
Time Frame	At end of treatment (Day 28)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Least Squares Mean (95% Confidence Interval) [mm]	19.7	21.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aprepitant 10 mg/g Gel, Aprepitant Gel Vehicle
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.51
	Confidence Interval	(2-Sided) 95%; -7.12 to 4.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pruritus by VAS (Visual Analogue Scale)
Description	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28), and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	50.8 (26.6)	58.1 (28.2)
Day 14 (Visit 3)	27.1 (24.2)	28.7 (19.1)
Day 28 (Visit 4)	19.0 (21.0)	21.9 (24.2)
Day 42 (Visit 5)	23.9 (28.2)	24.0 (26.7)

3. Secondary Outcome

Title	Change From Baseline in Participants' Global Assessment on Treatment Areas
Description	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42, participants assessed their prurigo on each treated area using the following score: 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. The change was calculated as the value at the later time point minus the value at baseline. The change at Day 1 was therefore 0 and negative values represent a decrease in score.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	0.0 (0.0)	0.0 (0.0)
Day 14 (Visit 3)	-0.5 (0.8)	-0.7 (0.9)
Day 28 (Visit 4)	-0.6 (1.1)	-0.7 (1.1)
Day 42 (Visit 5)	-0.3 (0.9)	-0.4 (0.9)

4. Secondary Outcome

Title	Clinical Score Assessment of Crusting
Description	The (sub)investigator assessed the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Crusts Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	1.3 (0.9)	1.4 (0.9)
Day 14 (Visit 3)	0.9 (0.9)	1.1 (0.8)
Day 28 (Visit 4)	0.7 (0.8)	1.0 (1.1)
Day 42 (Visit 5)	0.8 (0.8)	0.9 (0.7)

5. Secondary Outcome

Title	Clinical Score Assessment of Erythema
Description	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Erythema Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	2.0 (0.8)	2.1 (0.8)
Day 14 (Visit 3)	1.8 (0.9)	1.8 (0.9)
Day 28 (Visit 4)	1.5 (0.9)	1.7 (0.9)
Day 42 (Visit 5)	1.5 (0.8)	1.6 (0.7)

6. Secondary Outcome

Title	Clinical Score Assessment of Scratch Artefacts
Description	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Scratch artefacts: Superficial damage to the skin caused by severe scratching. Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	1.7 (1.1)	1.8 (1.1)
Day 14 (Visit 3)	1.3 (1.1)	1.3 (1.1)
Day 28 (Visit 4)	1.1 (1.0)	1.4 (1.1)
Day 42 (Visit 5)	1.4 (1.2)	1.4 (1.2)

7. Secondary Outcome

Title	Clinical Score Assessment of Infiltration
Description	The (sub)investigator will assess the clinical picture at each treated area at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 using the following score: Criteria: Infiltration Evaluation: 0 = not existing = mild = moderate = severe The score will be an integer on the scale 0-3.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	1.5 (1.2)	1.5 (1.1)
Day 14 (Visit 3)	1.3 (1.0)	1.4 (1.1)
Day 28 (Visit 4)	1.1 (0.9)	1.3 (1.0)
Day 42 (Visit 5)	1.3 (0.9)	1.5 (1.1)

8. Secondary Outcome

Title	Transepidermal Water Loss (TEWL)
Description	The (sub)investigator will made the following clinical assessment: Transepidermal water loss was defined as amount of released water from skin surface in g/cm^2 per hour. The TEWL is increased in case of damage of skin barrier.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	20.6 (13.6)	25.2 (12.8)
Day 14 (Visit 3)	22.7 (12.5)	24.0 (12.5)
Day 28 (Visit 4)	20.0 (19.5)	19.9 (21.3)
Day 42 (Visit 5)	19.4 (13.2)	19.9 (9.7)

9. Secondary Outcome

Title	Lesional Erythema by Mexameter
Description	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	438 (124)	453 (107)
Day 14 (Visit 3)	527 (122)	463 (119)
Day 28 (Visit 4)	464 (114)	491 (147)
Day 42 (Visit 5)	457 (120)	461 (144)

10. Secondary Outcome

Title	Non-lesional Erythema by Mexameter
Description	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed an erythema index (with a range between 0 and 999, where higher values indicate more erythema or redness) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lateral Side of Aprepitant 10 mg/g Gel	Lateral Side of Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	304 (151)	300 (145)
Day 14 (Visit 3)	287 (84.6)	312 (138)
Day 28 (Visit 4)	262 (104)	271 (71.8)
Day 42 (Visit 5)	284 (79.5)	284 (85.3)

11. Secondary Outcome

Title	Melanin by Mexameter
Description	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	131 (61.6)	115 (52.4)
Day 14 (Visit 3)	121 (43.8)	134 (56.8)
Day 28 (Visit 4)	152 (51.7)	139 (60.3)
Day 42 (Visit 5)	132 (73.2)	144 (77.5)

12. Secondary Outcome

Title	Non-lesional Melanin by Mexameter
Description	The skin colour of the participants was evaluated by use of a Mexameter spectrophotometer. The instrument computed a melanin index (with a range between 0 and 999, where higher values indicate more melanin) which may be used as an indication of skin properties. Mexameter measurements were performed at baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42 to assess stimulation of microcirculation, irritating effects, and occurring erythema.
Time Frame	At baseline (Day 1), Day 14, end of treatment (Day 28) and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Day 1 (Visit 2)	127 (58.9)	129 (49.0)
Day 14 (Visit 3)	165 (179)	215 (224)
Day 28 (Visit 4)	149 (117)	166 (170)
Day 42 (Visit 5)	129 (51.3)	179 (236)

13. Secondary Outcome

Title	Daily Assessments of Duration of Pruritus (Preceding 12 Hours)
Description	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the number of hours with pruritus within the last 12 hours on both areas by use of a 7-point scale (<0.5 hours, 0.5-1 hours, 1-2 hours, 3-4 hours, 5-6 hours, 7-8 hours, 9-12 hours). Duration of pruritus was categorized as follows: 1 if <0.5 hours, 2 if 0.5-1 hours, 3 if 1-2 hours, 4 if 3-4 hours, 5 if 5-6 hours, 6 if 7-8 hours and 7 if 9-12 hours. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.
Time Frame	From baseline to Day 31

Outcome Measure Data

Analysis Population Description

Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 19 participants analysed for some of the time points.

Arm/Group Title	Evening: Aprepitant 10 mg/g Gel	Evening: Aprepitant Gel Vehicle	Morning: Aprepitant 10 mg/g Gel	Morning: Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	19	19	19	19
Day -1	3.7 (1.9)	4.0 (2.1)	NA (NA)	NA (NA)
Day 1	3.5 (1.7)	3.7 (1.6)	3.0 (1.8)	3.4 (1.8)
Day 2	3.0 (1.6)	3.3 (1.7)	3.2 (1.2)	3.3 (1.3)
Day 3	2.9 (1.4)	3.3 (1.6)	2.9 (1.1)	3.1 (1.3)
Day 4	2.7 (1.3)	3.1 (1.4)	2.8 (1.4)	3.1 (1.5)
Day 5	2.1 (1.2)	2.7 (1.5)	2.2 (1.2)	2.8 (1.3)
Day 6	2.5 (1.3)	2.9 (1.4)	2.3 (1.3)	2.6 (1.5)
Day 7	2.6 (1.3)	2.9 (1.4)	2.5 (1.5)	2.7 (1.6)
Day 8	2.4 (1.3)	2.7 (1.5)	2.3 (1.4)	2.6 (1.5)
Day 9	2.4 (1.3)	2.8 (1.4)	2.4 (1.3)	2.8 (1.3)
Day 10	2.4 (1.3)	2.6 (1.5)	2.4 (1.3)	2.5 (1.4)
Day 11	2.2 (1.4)	2.8 (1.5)	2.0 (1.3)	2.4 (1.4)
Day 12	2.1 (1.3)	2.5 (1.4)	2.2 (1.3)	2.7 (1.3)
Day 13	2.4 (1.6)	2.7 (1.5)	2.2 (1.5)	2.5 (1.4)
Day 14	2.1 (1.3)	2.4 (1.4)	2.1 (1.4)	2.4 (1.3)
Day 15	2.4 (1.4)	2.5 (1.4)	2.1 (1.5)	2.5 (1.4)
Day 16	2.2 (1.3)	2.4 (1.4)	2.1 (1.2)	2.6 (1.2)
Day 17	2.2 (1.3)	2.5 (1.3)	2.1 (1.4)	2.6 (1.4)
Day 18	2.1 (1.3)	2.3 (1.2)	2.2 (1.3)	2.6 (1.3)
Day 19	2.1 (1.3)	2.4 (1.3)	1.9 (1.3)	2.3 (1.4)
Day 20	2.0 (1.2)	2.3 (1.2)	2.0 (1.2)	2.2 (1.2)
Day 21	2.0 (1.3)	2.2 (1.2)	1.9 (1.3)	2.1 (1.2)
Day 22	1.9 (1.1)	2.3 (1.2)	2.0 (1.3)	2.2 (1.2)
Day 23	2.3 (1.5)	2.4 (1.5)	2.0 (1.2)	2.3 (1.2)
Day 24	1.9 (1.2)	2.1 (1.2)	2.0 (1.2)	2.1 (1.2)
Day 25	2.3 (1.4)	2.5 (1.3)	1.9 (1.2)	2.1 (1.3)
Day 26	2.2 (1.2)	2.2 (1.3)	2.4 (1.5)	2.3 (1.5)
Day 27	2.0 (1.2)	2.1 (1.2)	2.1 (1.2)	2.2 (1.2)
Day 28	1.8 (1.2)	2.3 (1.2)	2.0 (1.2)	2.1 (1.2)
Day 29	1.0 (0.0)	2.0 (0.0)	1.5 (1.2)	1.7 (1.2)
Day 30	1.0 (NA)	2.0 (NA)	1.0 (0.0)	1.5 (0.7)
Day 31	NA (NA)	NA (NA)	1.0 (NA)	2.0 (NA)

14. Secondary Outcome

Title	Daily Assessments of Average Pruritus by Use of a VAS
Description	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the average intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1, before cream was applied.
Time Frame	From baseline to Day 31

Outcome Measure Data

Analysis Population Description

Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.

Arm/Group Title	Evening: Aprepitant 10 mg/g Gel	Evening: Aprepitant Gel Vehicle	Morning: Aprepitant 10 mg/g Gel	Morning: Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20	20	20
Day -1	49.1 (20.9)	51.3 (21.1)	NA (NA)	NA (NA)
Day 1	45.0 (21.5)	44.7 (21.7)	46.9 (21.6)	49.3 (20.6)
Day 2	35.1 (24.1)	38.9 (22.2)	38.3 (18.4)	39.2 (19.0)
Day 3	33.7 (21.0)	35.8 (20.4)	33.6 (21.0)	33.7 (19.7)
Day 4	31.8 (20.2)	37.5 (18.3)	34.5 (22.1)	37.2 (18.7)
Day 5	27.4 (19.6)	31.0 (18.0)	24.2 (16.3)	33.7 (16.9)
Day 6	26.4 (15.9)	31.5 (17.6)	26.8 (17.4)	30.3 (19.1)
Day 7	30.4 (21.7)	33.2 (22.2)	28.3 (20.9)	31.9 (21.9)
Day 8	23.3 (12.6)	28.8 (16.1)	26.5 (18.4)	30.1 (18.8)
Day 9	24.5 (16.6)	27.6 (17.9)	26.8 (17.1)	27.4 (16.0)
Day 10	22.0 (14.8)	28.2 (17.7)	30.6 (21.6)	30.2 (20.6)
Day 11	23.3 (18.8)	28.4 (19.1)	22.3 (15.2)	29.3 (19.0)
Day 12	19.9 (13.4)	23.7 (12.6)	23.0 (17.0)	27.8 (16.8)
Day 13	21.8 (26.0)	26.4 (14.8)	20.2 (13.4)	23.4 (14.5)
Day 14	20.9 (15.4)	23.1 (13.7)	21.9 (15.1)	24.7 (16.1)
Day 15	24.2 (16.9)	25.2 (16.0)	19.3 (14.6)	22.1 (13.0)
Day 16	20.8 (13.6)	24.3 (16.7)	22.7 (15.4)	25.4 (15.3)
Day 17	20.2 (14.6)	21.7 (14.8)	18.8 (14.4)	22.8 (14.3)
Day 18	18.5 (13.6)	21.1 (14.5)	21.6 (13.9)	22.8 (13.0)
Day 19	15.6 (11.2)	19.9 (16.0)	20.7 (14.9)	22.4 (14.7)
Day 20	16.0 (11.9)	19.7 (12.9)	17.8 (13.1)	18.6 (14.9)
Day 21	14.5 (14.6)	17.0 (16.4)	16.1 (13.2)	17.1 (12.4)
Day 22	14.3 (13.2)	15.9 (15.1)	15.3 (14.4)	16.6 (12.8)
Day 23	15.6 (13.6)	17.2 (14.3)	15.8 (16.0)	14.6 (12.7)
Day 24	15.7 (14.1)	16.7 (15.1)	16.5 (16.6)	15.5 (13.4)
Day 25	18.2 (16.4)	16.8 (14.0)	15.8 (14.8)	16.5 (17.0)
Day 26	15.1 (13.1)	16.6 (15.8)	19.8 (17.3)	16.3 (13.5)
Day 27	14.2 (15.4)	14.1 (12.9)	13.6 (13.8)	14.6 (13.0)
Day 28	7.8 (7.5)	11.6 (10.6)	16.4 (14.5)	14.9 (13.5)
Day 29	3.0 (2.8)	5.5 (2.1)	4.7 (6.1)	4.9 (5.6)
Day 30	3.0 (NA)	3.0 (NA)	3.5 (2.1)	3.5 (0.7)
Day 31	NA (NA)	NA (NA)	2.0 (NA)	2.0 (NA)

15. Secondary Outcome

Title	Daily Assessments of Maximum Intensity of Pruritus by Use of a VAS
Description	During the trial participants completed a diary twice daily, in the morning and in the evening, each covering the preceding 12 hours, which collected the maximum intensity of pruritus since last evaluation by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line. The evening baseline measure was taken on the evening of Day -1 and the morning baseline measure was taken on the morning of Day 1 before cream was applied.
Time Frame	From baseline to Day 31

Outcome Measure Data

Analysis Population Description

Results were collected from a diary that participants were requested to fill in twice a day. Some participants missed some of the entries so there are less than 20 participants analysed for some of the time points.

Arm/Group Title	Evening: Aprepitant 10 mg/g Gel	Evening: Aprepitant Gel Vehicle	Morning: Aprepitant 10 mg/g Gel	Morning: Aprepitant Gel Vehicle
Arm/Group Description	20 participants were treated with vehicle gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20	20	20
Day -1	61.1 (21.8)	62.7 (25.7)	NA (NA)	NA (NA)
Day 1	49.9 (25.4)	54.7 (24.6)	56.0 (25.3)	62.4 (22.0)
Day 2	43.2 (24.7)	46.7 (25.1)	48.8 (22.2)	46.7 (23.0)
Day 3	41.6 (24.7)	42.7 (24.8)	39.5 (24.5)	43.6 (23.5)
Day 4	37.7 (21.7)	42.8 (19.9)	39.5 (25.1)	47.7 (20.7)
Day 5	33.4 (23.4)	39.7 (23.6)	32.3 (20.1)	41.7 (21.9)
Day 6	34.1 (19.5)	38.4 (21.0)	34.3 (21.1)	39.1 (24.5)
Day 7	35.2 (23.5)	39.2 (24.2)	35.3 (23.5)	38.9 (24.5)
Day 8	31.4 (16.1)	37.4 (19.5)	32.2 (20.3)	40.7 (23.0)
Day 9	32.0 (20.0)	35.0 (21.5)	32.8 (18.8)	35.9 (18.5)
Day 10	29.4 (18.0)	34.5 (19.7)	40.0 (22.8)	41.1 (22.5)
Day 11	30.7 (22.4)	37.3 (23.0)	28.7 (17.8)	36.8 (21.1)
Day 12	27.1 (17.2)	31.8 (16.8)	31.6 (22.8)	38.6 (20.8)
Day 13	31.0 (21.9)	34.2 (21.8)	29.1 (21.7)	31.3 (21.3)
Day 14	27.1 (19.6)	31.2 (19.0)	30.7 (21.2)	31.9 (21.7)
Day 15	29.4 (19.0)	32.1 (18.9)	26.3 (19.1)	30.7 (19.3)
Day 16	28.2 (16.8)	32.8 (18.3)	29.1 (18.9)	32.9 (19.5)
Day 17	28.2 (19.1)	29.3 (21.8)	25.5 (16.7)	29.8 (17.1)
Day 18	25.6 (16.2)	27.7 (17.1)	29.2 (18.5)	30.4 (16.8)
Day 19	24.1 (15.7)	27.4 (19.8)	27.7 (20.2)	33.1 (21.7)
Day 20	25.1 (17.4)	27.1 (18.0)	23.2 (14.5)	23.5 (17.6)
Day 21	21.3 (19.5)	23.0 (19.0)	22.6 (16.2)	25.7 (19.7)
Day 22	20.8 (19.5)	21.5 (16.7)	20.1 (16.8)	22.7 (15.1)
Day 23	22.2 (17.9)	24.2 (18.0)	23.2 (22.3)	21.1 (16.7)
Day 24	21.1 (18.4)	22.0 (19.1)	20.8 (17.5)	21.1 (16.6)
Day 25	22.7 (19.3)	23.8 (21.3)	21.8 (20.1)	20.8 (17.3)
Day 26	23.2 (18.4)	24.0 (19.2)	24.1 (20.2)	23.1 (18.7)
Day 27	20.9 (21.8)	23.1 (21.3)	19.6 (18.6)	21.3 (18.8)
Day 28	12.6 (11.9)	18.9 (20.1)	24.7 (19.9)	24.7 (21.7)
Day 29	3.5 (2.1)	7.5 (0.7)	5.7 (7.0)	5.9 (4.3)
Day 30	2.0 (NA)	4.0 (NA)	4.5 (0.7)	5.5 (0.7)
Day 31	NA (NA)	NA (NA)	3.0 (NA)	4.0 (NA)

16. Secondary Outcome

Title	Percent Change From Baseline in Pruritis Assessed by VAS at End of Treatment
Description	On the last day of treatment, participants assessed the change of pruritus compared to baseline in percentage by use of a VAS (ranging from 0 to 100). The participants assessed the intensity of present pruritus of each treated area on a visual analogue scale (VAS) with a score of "0" (no itch at all) to "10" (worst imaginable itch) at the two extremes on a 100 mm line.
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aprepitant 10 mg/g Gel	Aprepitant Gel Vehicle
Arm/Group Description	20 participants treated with aprepitant 10 mg/g gel on either left or right extremity	20 participants were treated with vehicle gel on either left or right extremity
Measure Participants	20	20
Mean (Standard Deviation) [percent change]	50.8 (28.1)	41.7 (29.2)

Adverse Events

Time Frame	From Day 1 to Day 42
Arm/Group Title	Treatment Not Defined		Aprepitant Gel Vehicle		Aprepitant Gel
Arm/Group Description	The treatment for these adverse events are not defined		Placebo (Aprepitant gel vehicle)		10 mg/g aprepitant gel
All Cause Mortality
	Treatment Not Defined		Aprepitant Gel Vehicle		Aprepitant Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Treatment Not Defined		Aprepitant Gel Vehicle		Aprepitant Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Not Defined		Aprepitant Gel Vehicle		Aprepitant Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/20 (50%)		15/20 (75%)		11/20 (55%)
Eye disorders
Visual impairment	1/20 (5%)		0/20 (0%)		0/20 (0%)
General disorders
Application site discolouration	0/20 (0%)		0/20 (0%)		1/20 (5%)
Application site discomfort	0/20 (0%)		2/20 (10%)		4/20 (20%)
Application site erythema	0/20 (0%)		1/20 (5%)		1/20 (5%)
Application site haemorrhage	0/20 (0%)		1/20 (5%)		0/20 (0%)
Application site nodule	0/20 (0%)		1/20 (5%)		1/20 (5%)
Application site pain	0/20 (0%)		11/20 (55%)		8/20 (40%)
Application site paraesthesia	0/20 (0%)		2/20 (10%)		1/20 (5%)
Application site pruritus	0/20 (0%)		1/20 (5%)		1/20 (5%)
Application site urticaria	0/20 (0%)		1/20 (5%)		2/20 (10%)
Application site vesicles	0/20 (0%)		1/20 (5%)		1/20 (5%)
Fatigue	1/20 (5%)		0/20 (0%)		0/20 (0%)
Infections and infestations
Nasopharyngitis	3/20 (15%)		0/20 (0%)		0/20 (0%)
Postoperative wound infection	0/20 (0%)		0/20 (0%)		1/20 (5%)
Wound infection	0/20 (0%)		1/20 (5%)		0/20 (0%)
Metabolism and nutrition disorders
Hypercholesterolaemia	1/20 (5%)		0/20 (0%)		0/20 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/20 (5%)		0/20 (0%)		0/20 (0%)
Bursitis	1/20 (5%)		0/20 (0%)		0/20 (0%)
Nervous system disorders
Paraesthesia	2/20 (10%)		0/20 (0%)		0/20 (0%)
Psychiatric disorders
Insomnia	1/20 (5%)		0/20 (0%)		0/20 (0%)
Restlessness	1/20 (5%)		0/20 (0%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/20 (5%)		0/20 (0%)		0/20 (0%)
Sneezing	1/20 (5%)		0/20 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	2/20 (10%)		0/20 (0%)		0/20 (0%)
Erythema	1/20 (5%)		0/20 (0%)		0/20 (0%)
Rash	0/20 (0%)		1/20 (5%)		1/20 (5%)
Skin burning sensation	0/20 (0%)		1/20 (5%)		0/20 (0%)
Urticaria	1/20 (5%)		0/20 (0%)		0/20 (0%)
Surgical and medical procedures
Wound treatment	0/20 (0%)		1/20 (5%)		0/20 (0%)
Vascular disorders
Flushing	1/20 (5%)		0/20 (0%)		0/20 (0%)
Hot flush	1/20 (5%)		0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer or other outside person, the Investigator shall submit to LEO, in writing, a copy of the intended publication, describing the detail of any Research Results that the Investigator intends to Publish, at least 60 days before the date of the proposed submission for publication.